Dupixent sBLA accepted for FDA review for the treatment of chronic spontaneous urticaria Resubmission includes new pivotal data which confirm ...

The resubmitted sBLA will include results from Study C, which evaluated biologic-naive patients with uncontrolled CSU on antihistamines.

Chronic spontaneous urticaria is an inflammatory skin disease that causes hives that last for at least six weeks. Derms ...

With unfortunately no curative therapy for chronic spontaneous urticaria (CSU) available for now, the overall goal is to ...

Resubmission includes new pivotal data which confirm Dupixent significantly reduced itch and hive activityMore than 300,000 people in the U.S.

In May 2024, Novartis announced new data that confirm the long-term efficacy and safety of remibrutinib, a highly selective ...

Celldex Therapeutics, Longbio Pharma, Celltrion, Enanta Pharmaceuticals, Evommune, and others are evaluating new urticaria drugs to improve the treatment landscape. Promising pipeline urticaria ...

1 While second-generation H1-antihistamines are standard therapy for both acute and chronic urticaria, some patients need additional treatment to find relief. A new study investigates whether ...

The US Food and Drug Administration (FDA) has accepted for review the resubmission of the supplemental biologics license application (sBLA) for Dupixent (dupilumab) to treat adults and pediatric ...

Celldex Therapeutics, Longbio Pharma, Celltrion, Enanta Pharmaceuticals, Evommune, and others are evaluating new urticaria drugs to improve the treatment landscape. Promising pipeline urticaria ...